Prospective and Multicenter Study to Assess the Safety and Effectiveness of a Physiotherapy Treatment Through Fascial Therapy in Hemophilic Elbow Arthropathy. A Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change from baseline elbow joint bleeding frequency after treatment and at 3 months
研究概览
简要总结
Introduction: The common clinical manifestations of hemophilia are skeletal muscle bleeds, especially hematomas and hemarthrosis. Repeated episodes of joint bleeding in certain joints, causing a progressive joint deterioration. Secondary disorders to this joint degeneration include: biomechanical alterations, loss of range of movement and periarticular muscle atrophy.
Design. A prospective, multicenter and longitudinal pilot study to evaluate the efficacy of a treatment protocol with fascial therapy applied in patients with hemophilic arthropathy of the elbow.
Aimed: To evaluate the safety and efficacy of a physiotherapy treatment by fascial therapy in patients with hemophilic arthropathy of the elbow Patients: A total of 60 patients with hemophilia and prophylactic treatment will be recruited for inclusion in the study. Patients will be recruited in 6 centers, from different regions of Spain.
Intervention: Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
Measuring instruments and study variables: goniometric evaluation (range of movement); visual analog scale (joint pain); Haemophilia Joint Health Score (joint status); DASH Questionnaire (functionality of upper limbs); SF-36 Questionnaire (perception of quality of life). At the same time, the study will allow to determine joint bleeding caused by applied physiotherapy treatment.
Expected results: First, it is intended to demonstrate the safety of this physiotherapy technique in patients with hemophilia. Likewise, an improvement in the perception of elbow pain and joint mobility is expected. An improved functionality of the upper limb is also foreseen and with it, an enhanced perception of quality of life of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hemophilia A and B
- •Patients adults (over 18 years)
- •Patients diagnosed with hemophilic arthropathy of the elbow (by clinical assessment with the Hemophilia Joint Health Score)
- •Patients pn prophylactic treatment with FVIII / FIX concentrates.
排除标准
- •Patients without ambulation ability
- •Patients with inhibitors
- •Patients with neurological or cognitive alterations that impede the comprehension of the questionnaires and physical tests
- •Patients who have not signed the informed consent document.
研究组 & 干预措施
Control group
Subjects included in the control group will not receive physical therapy through fascial therapy and will continue with their usual routine of physical activity and exercise, and with the same pharmacological treatment regimen with FVIII / FIX. At the end of the study period the intervention will be applied under the same conditions as the experimental group, analyzing the overall sample at the end of the study.
Expermiental group
All patients included in the experimental group should be on prophylactic treatment with FVIII / FIX concentrates. Likewise, the factor should be administered on the same day that they receive each of the fascial therapy treatment sessions. Each session will last approximately 50 minutes, with three physiotherapy sessions taking place over a period of 3 weeks. The treatment program includes 11 maneuvers that must be administered bilaterally:
干预措施: Experimental group (Other)
结局指标
主要结局
Change from baseline elbow joint bleeding frequency after treatment and at 3 months
时间窗: Screening visit, within the first seven days after treatment and after three months follow-up visit
After the first session of physiotherapy patients will be given a self-register where they can record all the observations they feel (from hematomas or hemarthros, to any other discomfort or perception). Similarly, the principal investigator of the study will monitor all patients within 48 hours after each physical therapy session.
次要结局
- Change from baseline elbow joint status after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
- Change from baseline quality of life after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
- Change from baseline range of motion of elbow after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
- Change from baseline joint pain of elbow after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
- Change from baseline upper limb functionality after treatment and at 3 months(Screening visit, within the first seven days after treatment and after three months follow-up visit)
研究者
Rubén Cuesta-Barriuso, PhD
Principal Investigator
Real Fundación Victoria Eugenia